(120 days)
No
The description focuses on using standard ECG techniques to monitor the P-wave for catheter tip placement and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is used for positioning and confirmation of PICC tip placement, which is a diagnostic and guidance function, not a therapeutic one that directly treats a medical condition.
No
The Celerity System is intended for positioning PICCs by providing real-time catheter tip location information, not for diagnosing a disease or condition in a patient.
No
The device description explicitly mentions "The Celerity™ ECG Cable Accessory Pack consists of a sterile remote cover and a specialized alligator PICC clip," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the positioning of PICC lines and providing real-time catheter tip location information using the patient's cardiac electrical activity (ECG). This is a procedural guidance and monitoring function, not a diagnostic test performed in vitro on biological samples.
- Device Description: The device consists of an ECG cable accessory pack (remote cover and alligator clip) used in conjunction with the Celerity System to display ECG waveforms. This is hardware for physiological monitoring during a medical procedure.
- Lack of In Vitro Testing: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) outside of the body.
- Focus on Physiological Measurement: The core function is based on measuring the patient's cardiac electrical activity in vivo.
IVD devices are specifically designed to perform tests on biological specimens in vitro to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Celerity™ System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:
- · Atrial fibrillation
- · Atrial flutter
- · Severe tachycardia
- · Pacemaker-driven rhythm
- · Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The Celerity™ ECG Cable Accessory Pack consists of a sterile remote cover and a specialized alligator PICC clip. The Celerity™ ECG Cable Accessory Pack is designed to be used in conjunction with the Celerity™ System to provide a continuous display of electrocardiograph waveforms to guide placement of peripherally-inserted central catheters in the patient's right atrium of the heart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's right atrium of the heart
Indicated Patient Age Range
Adults (18 years or older)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted to demonstrate substantial equivalence of the Celerity™ ECG Cable Accessory Pack to the predicate devices:
| Item | Test Name |
|---|---|
| 1 | Alligator Clips – 1 year accelerated aging |
| 2 | Alligator Clips – 3 year accelerated aging |
| 3 | Equipment Interaction of Alligator Clips, ECG Electrodes, and ECG Snap Leads |
| 4 | Probe Cover – 1 year accelerated aging |
| 5 | Celerity Accessory Pack – 1 year accelerated aging |
| 6 | Celerity Accessory Pack – 3 year accelerated aging |
| 7 | Celerity Accessory Packs – ISTA 2A Shipping Test |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K142889 - AngioDynamics Inc. Celerity™ PICC Tip Confirmation System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Celerity™ PICC Tip Confirmation System" (510(k)# K142889)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
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October 26, 2017
Medical Components, Inc. (dba Medcomp®) Colton Muraira Regulatory Affairs 1499 Delp Dr. Harleysville, Pennsylvania 19438
Re: K171931
Trade/Device Name: Celerity™ ECG Cable Accessory Pack Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: September 15, 2017 Received: September 26, 2017
Dear Colton Muraira:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina Kiang
S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
K171931
Device Name
Celerity ECG Cable Accessory Pack
Indications for Use (Describe)
The Celerity System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:
- · Atrial fibrillation
- · Atrial flutter
- · Severe tachycardia
- · Pacemaker-driven rhythm
- · Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.
Type of Use (Select one or both, as applicable)
× | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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K171931 510(K) SUMMARY
| Manufacturer's Name: | Medical Components, Inc. (dba Medcomp®)
1499 Delp Drive
Harleysville, PA 19438 |
|---------------------------|--------------------------------------------------------------------------------------|
| Corresponding Official: | Colton Muraira
Regulatory: North America and EU |
| Telephone Number: | (215) 256-4201, x 2285 |
| Email: | CMuraira@Medcompnet.com |
| Preparation Date: | October 23, 2017 |
| Trade Name: | Celerity™ ECG Cable Accessory Pack |
| Common or Usual Name: | PICC Placement Accessory |
| Regulation Name: | Percutaneous, implanted, long-term
intravascular catheter |
| Regulation Number: | 21 CFR 880.5970 |
| Product Code: | LJS |
| Device Class: | Class II |
| Primary Predicate Device: | K142889 - AngioDynamics Inc. Celerity™ PICC Tip Confirmation
System |
Device Description:
The Celerity™ ECG Cable Accessory Pack consists of a sterile remote cover and a specialized alligator PICC clip. The Celerity™ ECG Cable Accessory Pack is designed to be used in conjunction with the Celerity™ System to provide a continuous display of electrocardiograph waveforms to guide placement of peripherally-inserted central catheters in the patient's right atrium of the heart.
Indications For Use
The Celerity™ System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
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Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:
- । Atrial fibrillation
- Atrial flutter -
- -Severe tachycardia
- Pacemaker-Driven Rhythm -
- -Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of an additional method is necessary to confirm catheter tip location.
Substantial Equivalence Discussion
The subject device is an accessory pack to the Celerity System. The subject device accessory pack consists of a sterile remote cover and a specialized alligator PICC clip. Both devices use changes in cardiac electrical activity to provide real-time catheter tip location.
Celerity™ ECG Cable Accessory Pack has been compared to the cleared "Celerity™ PICC Tip Confirmation System" (510(k)# K142889) as a reference for substantial equivalence. A table comparing the two devices is provided as follow:
| Attribute | Subject Device – K171931:
Celerity ECG Cable Accessory
Pack | Predicate Device – K142889 :
Celerity PICC Tip Confirmation
System | Comparison | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 510(k) Holder | Medcomp, Inc | AngioDynamics | N/A | |
| Design | The Celerity ECG Cable
Accessory Pack is designed to be
used in conjunction with the
Celerity™ System to provide a
continuous display of
electrocardiograph [ECG]
waveforms to guide placement of
peripherally-inserted central
catheters [PICC] in the patient's
right atrium of the heart.
Sterile remote cover: covers a
sufficient length of the remote
control cable to provide a sterile
barrier capable of being pierced by
the remote control PICC
connector.
Sterile PICC Clip Connector: | The Celerity PICC Tip
Confirmation System is an
accessory to peripherally-inserted
central catheters (PICC). It aids a
clinician in placing PICC
optimally, in the superior vena
cava near the entrance to the right
atrium of the heart. | Components
Same | |
| | Capable of conducting an ECG
signal from the PICC stylet to the
Celerity remote control. | To provide real time tip location
information of a central venous
catheter by utilization of ECG to
observe P-wave changes as the tip
approaches the right atrium of the
heart via the superior vena cava. | To provide real time tip location
information of a central venous
catheter by utilization of ECG to
observe P-wave changes as the tip
approaches the right atrium of the
heart via the superior vena cava. | Same |
| Intended use | | | | |
| Indications for
use | The Celerity ECG Cable
Accessory Pack is indicated for the
positioning of Peripherally
Inserted Central Catheters (PICC)
in adult patients. It provides real-
time catheter tip location
information by using the patient's
cardiac electrical activity. The
Celerity System is indicated for
use as an alternative method to
chest x-ray or fluoroscopy
confirmation of PICC tip
placement in adult patients.
Note: In general, devices that
utilize ECG technique to observe
P-wave are limited, but not
contraindicated for patients where
cardiac rhythms may change
presentation of the P-wave;
including:
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-Driven Rhythm
- Chronic obstructive
pulmonary disease (COPD)
Such patients are easily identified
prior to PICC insertion. Use of an
additional method is necessary to
confirm catheter tip location. | The Celerity System is indicated
for the positioning of Peripherally
Inserted Central Catheters (PICC)
in adult patients. It provides real-
time catheter tip location
information by using the patient's
cardiac electrical activity. The
Celerity System is indicated for
use as an alternative method to
chest x-ray or fluoroscopy
confirmation of PICC tip
placement in adult patients.
Note: In general, devices that
utilize ECG technique to observe
P-wave are limited, but not
contraindicated for patients where
cardiac rhythms may change
presentation of the P-wave;
including:
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-Driven Rhythm
- Chronic obstructive
pulmonary disease (COPD)
Such patients are easily identified
prior to PICC insertion. Use of an
additional method is necessary to
confirm catheter tip location. | Same | |
| Target
Population | Adults (18 years or older) | Adults (18 years or older) | Same | |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same | |
| Materials | ECG Clip Cable: nickel plated
steel with a white PVC insulator.
The audio connector consists of a
nylon and polyethylene insulator
and gold or nickel plated contacts
Remote Cover: latex-free
polyethylene | ECG Clip Cable: nickel plated
steel with a white PVC insulator.
The audio connector consists of a
nylon and polyethylene insulator
and gold or nickel plated contacts
Remote Cover: latex-free
polyethylene | Same | |
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7
The indications for use statement and the intended use of the subject device are identical to the predicate device. The differences between the subject device and the predicate device are:
-
- Proposed device is an accessory pack containing separate components to be used with the predicate Celerity System, which already contains stated components.
-
- Different manufacturer of the ECG Clip Cable and Remote Cover
Based on the aforementioned modifications to the subject device, the subject device does not raise different types of safety and effectiveness questions when compared to the predicate device.
Bench/Performance/Non-Clinical Testing
The following testing was conducted to demonstrate substantial equivalence of the Celerity™ ECG Cable Accessory Pack to the predicate devices:
| Item | Test Name |
|---|---|
| 1 | Alligator Clips – 1 year accelerated aging |
| 2 | Alligator Clips – 3 year accelerated aging |
| 3 | Equipment Interaction of Alligator Clips, |
| ECG Electrodes, and ECG Snap Leads | |
| 4 | Probe Cover – 1 year accelerated aging |
| 5 | Celerity Accessory Pack – 1 year accelerated aging |
| 6 | Celerity Accessory Pack – 3 year accelerated aging |
| 7 | Celerity Accessory Packs – ISTA 2A Shipping Test |
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Biocompatibility
The subject device is non-patient contacting and therefore, biocompatibility testing is not applicable.
Conclusion
The modifications to the subject device include the change of the manufacture of the ECG Clip Cable and the Remote Cover and the packaging of the ECG Clip Cable and Remote Cover as an accessory pack. The modifications do not raise new or different questions of safety and effectiveness and are supported by non-clinical testing.
The Celerity ECG Cable Accessory Pack is substantially equivalent to the Celerity PICC Tip Confirmation System cleared under K142889.